Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Reopening of Comment Period, 5944 [E7-2123]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 26 (Thursday, February 8, 2007)]
[Proposed Rules]
[Page 5944]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2123]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 72, No. 26 / Thursday, February 8, 2007 / 
Proposed Rules

[[Page 5944]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 20, 201, 207, 314, 330, 514, 515, 601, 607, 610, and 
1271

[Docket No. 2005N-0403]
RIN 0910-AA49


Requirements for Foreign and Domestic Establishment Registration 
and Listing for Human Drugs, Including Drugs That Are Regulated Under a 
Biologics License Application, and Animal Drugs; Reopening of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening to 
February 26, 2007, the comment period for the proposed rule published 
in the Federal Register of August 29, 2006 (71 FR 51276). The proposed 
rule would amend the agency's current regulations governing 
establishment registration and drug listing. The initial comment period 
was extended (71 FR 63726, October 31, 2006) until January 26, 2007. We 
recently learned that, on January 26, 2007, the last day of the comment 
period, technical problems prevented some persons from submitting 
electronic comments. Therefore, FDA is reopening the comment period 
until February 26, 2007, to allow interested persons to submit comments 
for this rulemaking.

DATES: Submit written or electronic comments on the proposed rule by 
February 26, 2007.

ADDRESSES: You may submit comments, identified by Docket No. 2005N-0403 
and RIN 0910-AA49, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described previously in 
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No. and Regulatory Information Number (RIN) for this 
rulemaking. All comments received may be posted without change to 
https://www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For additional information on submitting 
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    For information concerning drugs regulated by the Center for Drug 
Evaluation and Research: John W. Gardner, Center for Drug Evaluation 
and Research (HFD-330), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-8920, john.gardner@fda.hhs.gov.
    For information concerning products regulated by the Center for 
Biologics Evaluation and Research: Valerie A. Butler, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210, valerie.butler@fda.hhs.gov.
    For information concerning animal drugs: Lowell Fried (HFV-212) or 
Isabel W. Pocurull (HFV-226), Center for Veterinary Medicine, Food and 
Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-
9059 or 240-453-6853, lowell.fried@fda.hhs.gov or 
isabel.pocurull@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the proposed rule 
(see DATES). Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with Docket No. 2005N-0403. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 1, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2123 Filed 2-7-07; 8:45 am]
BILLING CODE 4160-01-S